Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products
Stability is one of the critical aspects in ensuring safety and efficacy of drug products, and hence its assessment has gained a paramount importance in the pharmaceutical industry. However, the stability problems and assessment of stability of drug-loaded nanoformulations remain a very challenging aspect in the pharmaceutical field. The stability issues of drug nanoparticles could arise during manufacturing, storage, and shipping. Though, recent advancement in analytical technology has offered ample tools for stability assessment of nanopharmaceuticals, they have their own limitations in terms of efficiency. In this chapter, we summarize various stability testing parameters, techniques used in their evaluation and the issues related to stability testing of nanotechnology based drug products.
Key wordsNanoparticle Nano-formulation Nanotechnology Stability testing Nano-pharmaceuticals
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